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Completed

NCT Number: NCT02862236

The Acute Effect of Hypericum Perforatum on Short-Term Memory in Healthy Adults

Rationale Over-the-counter drugs containing hypericum perforatum (H. perforatum), have been argued to improve memory and sustained attention. So far, these claims have not been supported in human studies. However, previous studies used rather high dosages, and little is known about the acute effect of small dosages.

Objective We evaluated whether an acute treatment with Remotiv 500 and Remotiv 250 (500 or 250 mg of H. perforatum quantified to either 1 or 0.5 mg of hypericin) improved memory, sustained attention, as well as mood and state anxiety in healthy adults.

Method A single dosage, randomized, double blind, placebo-controlled trial was conducted with 82 student participants (33 women). Each participant received placebo in one session and one of two dosages in the other session. Order of the sessions and dosage conditions were randomized between subjects. Participants completed a battery of tasks assessing short-term memory capacity and sustained attention.

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Key information

Conditions

Subclinical Anxious Adults Healthy Adults Nootropic Potential of Hypericum and Alprazolam

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Technion, Israel Institute of Technology

Haifa, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy adults 18 to 40 years old.

Exclusion criteria

  • 1. Demographics: Under 18 years of age or older than 40; pregnant or nursing women; non-fluent Hebrew speakers.
  • Body weight: less than 50 kg and more than 90 kg (to ensure effective drug dosage).
  • Mental health: Diagnosed with any DSM-V disorder (including ADHD, learning disabilities). These DSM-V disorders may be included in the research: sexual dysfunctions, sleeping disorders and mild-moderate anxiety disorders.
  • Any motor disability hampering a participant's ability to perform the experimental task.
  • Consumption of any psychoactive substance within the last 72 hours. 6. Ongoing medical problems or use of any substances (e.g., other prescribed medications) which may interact negatively with any of the three drugs used in the experiment.

Treatment and study plan

Hypericum perforatum extract

Drug

250 or 500 mg Remotiv capsules of hypericum perforatum extract, p.o.

Primary outcomes

  1. Go/no-go task

    Time frame: one-two hours after drug administration

    A computerized cognitive task: aimed to measure attention and impulsivity: errors of omission and commission

  2. Digit span task

    Time frame: one-two hours after drug administration

    A computerized cognitive task; accuracy of recalling

  3. Symmetry span task

    Time frame: one-two hours after drug administration

    A computerized cognitive task; accuracy of responses

  4. Operation span task

    Time frame: one-two hours after drug administration

    A computerized cognitive task; accuracy of responses

  5. Groton's Maze task

    Time frame: one-two hours after drug administration

    A computerized task

Secondary outcomes

  1. DASS-21

    Time frame: one-two hours after drug administration

    A self-report questionnaire; scoring of relevant state anxiety items

  2. PANAS

    Time frame: one-two hours after drug administration

    A self-report questionnaire

  3. STAI

    Time frame: one-two hours after drug administration

    A self-report questionnaire; scoring of relevant state anxiety items

Sponsors and collaborators

Lead sponsor

Prof. Eldad Yechiam

Other

Collaborators

  • Beer Yaakov - Ness Ziona Mental Health Center

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 10, 2016
Registry last updated
Sep 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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